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NCT Number: NCT05377580

A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis

To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

This is a phase 2 randomized,double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI112 induction and maintenance therapy in subjects with moderate to severe active ulcerative colitis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidence supporting UC and histopathological evidence supporting UC diagnosis;
  • Patients with moderate to severe ulcerative colitis, defined as modified Mayo Score ≥4 and endoscopic score ≥2;
  • Subject must have received at least one prior treatment or first use of a biological agent:

Exclusion criteria

  • Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease;
  • UC lesions were limited to rectum or involved colon < 15cm;
  • Evidence of toxic hirschsprung's disease was found during screening;
  • History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;

Treatment and study plan

Period 1 IBI112 Placebo

Drug

Intravenous Injection

Other names: Placebo

Period 2 IBI112 dose 3

Drug

Subcutaneous injections

Other names: IBI112 dose 3

Period 1 IBI112 dose 1

Drug

Intravenous Injection

Other names: IBI112 dose 1

Period 1 IBI112 dose 2

Drug

Intravenous Injection

Other names: IBI112 dose 2

Period 2 IBI112 dose 4

Drug

Intravenous Injection

Other names: IBI112 dose 4

Period 2 IBI112 Placebo

Drug

Subcutaneous injections

Other names: Placebo

Primary outcomes

  1. Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC)

    Time frame: week 12

    Percentage of subjects who achieved clinical remission at week 12.

Secondary outcomes

  1. The proportion of participants achieving a clinical response at Week 12.

    Time frame: week 12

    Clinical response is defined as a relative decrease from baseline in the modified Mayo score of ≥30% and ≥2 points, along with a relative decrease in the rectal bleeding subscore of ≥1 point or an absolute subscore of 0 or 1.

  2. The proportion of participants achieving symptomatic relief at Week 12.

    Time frame: week 12

    Symptomatic relief is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

  3. The proportion of participants achieving endoscopic remission at Week 12.

    Time frame: week 12

    Endoscopic remission is defined as an endoscopic subscore of 0 or 1 within the modified Mayo score.

  4. The proportion of participants achieving mucosal healing at Week 12.

    Time frame: week 12

    Mucosal healing is defined as endoscopic remission, which means an endoscopic subscore of 0 or 1 within the modified Mayo score, and central Geboes histopathological index remission.

  5. The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period.

    Time frame: week 52

  6. The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period.

    Time frame: week 52

  7. The proportion of participants achieving symptomatic relief at Week 52 during the maintenance treatment period.

    Time frame: week 52

  8. The proportion of participants achieving mucosal healing at Week 52 during the maintenance treatment period.

    Time frame: week 52

  9. The proportion of participants achieving endoscopic remission at Week 52 during the maintenance treatment period.

    Time frame: week 52

  10. The change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period.

    Time frame: Week 12, Week 52，Weeks 24 and 64

  11. The change from baseline in the 36-item Short Form Health Survey (SF-36) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period.

    Time frame: Week 12, Week 52，Weeks 24 and 64

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI112 in Patients With Moderate to Severe Active Ulcerative Colitis

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 17, 2022
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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